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UPDATE 1-Pozen says FDA rejects lead drug again
December 17, 2014 / 1:21 PM / 3 years ago

UPDATE 1-Pozen says FDA rejects lead drug again

(Adds detail, background; updates shares)

Dec 17 (Reuters) - Pozen Inc said two versions of its experimental heart drug were rejected for the second time by the U.S. Food and Drug Administration, which again cited deficiencies in the manufacturing plant of a supplier of an active ingredient.

Pozen’s shares fell nearly 23 percent to $6.99 in premarket trading on Wednesday.

The drugs, PA8140 and PA32540, are being developed for the secondary prevention of cardiovascular disease in patients at risk for aspirin-associated gastric ulcers.

The FDA reiterated on Wednesday that there were “no clinical or safety deficiencies” related to either drugs.

Pozen, which first received the rejection in late April, said the supplier had responded to FDA in May with a plan to correct all the issues.

However, there has been no re-inspection of the plant since April, the company said.

Pozen said the supplier had also received no communication with respect to the plan of action, except that the matter is under review.

The company said it believed that the issues raised during the April inspection have been adequately addressed based on inspections by a consultant it had hired and its review of relevant documents.

French drugmaker Sanofi SA earlier this month ended a licensing deal with Pozen to commercialize the drugs, citing the longer-than-expected regulatory timeline.

The FDA had set an action date of Dec. 30 to decide on Pozen’s re-submission.

Chapel Hill, North Carolina-based Pozen’s stock closed at $9.03 on the Nasdaq on Tuesday.

Reporting by Anjali Rao Koppala and Natalie Grover in Bengaluru; Editing by Saumyadeb Chakrabarty and Sriraj Kalluvila

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